B Braun 5% Glucose Intravenous Infusion BP 250 mL Bottle

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
24-08-2020
Shusha Tabia za bidhaa (SPC)
24-08-2020

Viambatanisho vya kazi:

glucose monohydrate, Quantity: 55 g/L

Inapatikana kutoka:

B Braun Australia Pty Ltd

INN (Jina la Kimataifa):

glucose monohydrate

Dawa fomu:

Injection, intravenous infusion

Tungo:

Excipient Ingredients: water for injections

Njia ya uendeshaji:

Intravenous

Vitengo katika mfuko:

250ml

Dawa ya aina:

Not scheduled. Not considered by committee

Matibabu dalili:

For intravenous fluid therapy designed to correct deficiencies in hydration, electrolyte and energy levels. May also be used as solvents for intravenously administered drugs where compatibility has been established.

Bidhaa muhtasari:

Visual Identification: Clear, colourless solution practically free of particles; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2004-11-04

Taarifa za kipeperushi

                                1
CONSUMER MEDICINE INFORMATION
B. BRAUN (AUST) INTRAVENOUS REPLACEMENT FLUIDS
*
0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION BP
*
5% GLUCOSE INTRAVENOUS INFUSION BP
*
0.9% SODIUM CHLORIDE AND 5% GLUCOSE INJECTION BP
*
COMPOUND SODIUM LACTATE INJECTION BP (HARTMANN’S SOLUTION)
_THIS LEAFLET PROVIDES A SUMMARY OF SOME OF THE IMPORTANT THINGS YOU
NEED TO KNOW ABOUT _
_THIS MEDICINE. ONLY YOUR DOCTOR AND PHARMACIST ARE ABLE TO WEIGH UP
ALL THE RELEVANT FACTS _
_ABOUT THE USE OF THIS MEDICINE IN YOUR CONDITION AND YOU SHOULD
CONSULT THEM FOR FURTHER _
_DETAILS. MORE DETAILED AND TECHNICAL INFORMATION IS AVAILABLE ON
REQUEST FROM YOUR DOCTOR _
_OR PHARMACIST. _
The solutions described above are clear colourless solutions intended
for intravenous
infusion. They contain water and various electrolytes i.e. simple
chemicals such as sodium,
calcium, potassium etc. Some also contain glucose as a source of
energy.
COMPOSITION: The solutions have the following formulations (g/L):
0.9%
NACL
5%
GLUCOSE
0.9% NACL
AND 5%
GLUCOSE
COMPOUND
SODIUM
LACTATE
SODIUM
CHLORIDE
9g
---
9g
6g
GLUCOSE
MONOHYDRATE
---
55g
55g
---
POTASSIUM
CHLORIDE
---
---
---
0.4g
CALCIUM
CHLORIDE
---
---
---
0.27g
SODIUM
LACTATE
(AS 50% SOLN)
---
---
---
3.12
Solutions containing 5% glucose provide 835kJ/L.
WHAT ARE THE PRODUCTS USED FOR? Electrolyte replacement solutions are
used to replace fluid
and electrolytes which have been lost from the body due to illness or
injury.
HOW DO THEY WORK? The solution chosen by your doctor is infused slowly
into a vein and
provides water as well as some or all of the following electrolytes:
sodium, chloride,
potassium and bicarbonate ions to replace those lost. The solution may
also contain glucose.
BEFORE USING THIS PRODUCT: Please note that the solutions should not
be used if the container
is found to be leaking or the solution is not clear.
2
* Tell your doctor if you have kidney or liver problems or if you have
high levels of
potassium in your blood.
DIRECTIONS FOR USE: This product has been chosen by your doctor and
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Tabia za bidhaa

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Composition: The solutions have the following formulations (g/L):
0.9%
5%
0.9% NaCl
Compound
NaCl
Glucose
and 5%
Na Lactate
Glucose
and have the following content of electrolytes (mmol/L), total
osmolarity and pH:
0.9%
5%
0.9% NaCl
Compound
NaCl
Glucose
and 5%
Na Lactate
Glucose
Total Osmolarity
308 mOsm/L
278 mOsm/L
585 mOsm/L
278 mOsm/L
pH
4.5 – 7.0
3.5 - 5.5
3.5 - 5.5
5.0 - 7.0
Solutions containing 5% glucose provide 835kJ/L.
Description:
B. Braun intravenous replacement solutions are clear to colourless
solutions intended for intravenous infusion.
Pharmacology:
B. Braun intravenous replacement solutions provide various elec-
trolytes and/or glucose in sterile solutions intended for intravenous
infusion. The
solutions are all nominally isotonic, except for the sodium
chloride/glucose solutions
which are hypertonic.
Sodium chloride, potassium chloride and calcium chloride are present
in the various
solutions in concentrations suitable for replacement therapy under
different clinical
conditions (see indications). Sodium lactate is included as a source
of bicarbonate
ions following metabolism of lactate ions _in vivo._
Glucose is a necessary part of intravenous therapy regimes where the
supply of ener-
gy is a requirement. Glucose is the only natural substrate directly
utilised by all body
tissues and is essential for energy supply to the brain, peripheral
nerves, red blood
cells, bone marrow and the renal medulla.
Indications: The solutions are indicated for intravenous fluid therapy
designed to
correct deficiencies in hydration, electrolyte and energy levels. The
solutions may
also be used as solvents for intravenously administered drugs where
compatibility
has been established.
- 0.9% sodium chloride injection may also be used for irrigation of
wounds and
moistening of wound dressings
- Compound Sodium Lactate Solution is particularly suitable for the
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